Clinical Operation Manager - Investigator Site Contract Mgr

Our teams are growing!

We are looking for a Clinical Operation Manager | Investigator Site Contracts Manager to work fully dedicated to one of our biggest sponsor.

You will perform tasks at a country level associated with vendor management activities, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires good project leadership skills.

Responsibilities include, but are not limited to:

• Vendor, laboratories and technical supplies management.
• Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close- out. Support of Financial forecasting in conjunction with other roles.
• Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Provide support and oversight to local vendors as applicable.
• Coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
• Support of local regulatory and financial compliance. Ability to communicate well with investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
• Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations,
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
• Contributes to team knowledge by sharing best practices as appropriate/required.

Requirements:

• 3-5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
• Knowledge of budget and contract negotiations, local submission and approval processes, and understanding of how these impact study start-up.
• Requires strong understanding of local regulatory environment.
• Advanced level of English and local language.
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

What we offer:

• Great onboarding process to ensure successful integration, during the first 3 month you will be able to go to the office at least 1 day per week.
• Homebased position

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at https://jobs.iqvia.com